Trial record 3 of 1536 for:    Open Studies | "Body Weight"

Computer-Based Weight Maintenance in Primary Care (MAINTAIN-PC)

This study is not yet open for participant recruitment.
Verified September 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margaret (Molly) Conroy, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01946191
First received: September 16, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

The purpose of this study is to test whether online tracking tools and weight maintenance coaching visits for patients and real-time electronic progress reports for primary care providers (PCPs) [Continued Coaching (CC)] will support more successful weight maintenance than online tracking tools alone [Tracking Only (TO)] in a group of primary care patients who have lost ≥ 5% of their body weight.


Condition Intervention
Body Weight
Weight Loss
Motor Activity
Behavioral: Health coach electronic communication and support
Behavioral: Online self-monitoring
Behavioral: Real-time updates to Primary Care physicians

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Body weight [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Change in body weight from baseline (day 1) until the end of study (36 months).


Secondary Outcome Measures:
  • Maintenance of 5% weight loss [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Secondarily, we will also assess the maintenance of a 5% weight loss from baseline (day 1) to end of study (36 months).

  • BMI [ Time Frame: Day 1 vs. 36 Months ] [ Designated as safety issue: No ]
    Change in body mass index from baseline (day 1) to the end of the study (36 months).


Other Outcome Measures:
  • Patient Satisfaction [ Time Frame: 12 Months and 36 Months ] [ Designated as safety issue: No ]
    Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (36 months).

  • PCP Satisfaction [ Time Frame: 12 Months and 36 Months ] [ Designated as safety issue: No ]
    PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (36 months).


Estimated Enrollment: 196
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continued Coaching (CC)
Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians
Behavioral: Health coach electronic communication and support
Health coach reviews responses to weight-related surveys and provides feedback and advice
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Behavioral: Real-time updates to Primary Care physicians
Primary care physicians will receive updates through electronic health record system before each scheduled appointment
Active Comparator: Tracking Only (TO)
Online self-monitoring
Behavioral: Online self-monitoring
Tracking weight, calories, fat grams, and physical activity in electronic personal health record

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • Intentional & verified weight loss of greater than or equal to 5% of body weight in past year with previous BMI greater than or equal to 25.
  • Patient of participating PCP
  • Has/willing to get electronic personal health record account

Exclusion Criteria:

  • Unable to perform moderate exercises according to PCP
  • Current or planned pregnancy
  • Currently breastfeeding
  • Recent or planned bariatric surgery
  • Edema due to medical condition
  • No access to computer
  • Treated for cancer or thyroid disease in past year
  • Unable to attend group session or comply with requirements
  • Any other reason as determined by the Principal Investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946191

Contacts
Contact: Kimberly A Huber, MPH 412-605-0683 MAINTAIN@pitt.edu

Locations
United States, Pennsylvania
Center for Research on Health Care Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kimberly A Huber, MPH    412-605-0683    MAINTAIN@pitt.edu   
Principal Investigator: Margaret B Conroy, MD, MPH         
Sub-Investigator: Kathleen M McTigue, MD, MS         
Sub-Investigator: Rachel Hess, MD, MSc         
Sub-Investigator: Cindy Bryce, PhD         
Sub-Investigator: Gary Fischer, MD         
Sub-Investigator: Dana Tudorascu, PhD         
Sub-Investigator: Laurey R Simkin-Silverman, PhD, MA         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Margaret B Conroy, MD, MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Margaret (Molly) Conroy, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01946191     History of Changes
Other Study ID Numbers: 1R18HS021162
Study First Received: September 16, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Weight maintenance
Electronic health record
Primary care

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014